title: Assessment of the safety of intrauterine instillation of heated saline for endometrial ablation.
abstract: OBJECTIVE
  To evaluate the safety of pressure, temperature-controlled, continuously circulating hot saline (EnAbl system, InnerDyne Medical, Sunnyvale, CA) for endometrial ablation using the in vivo human uterus.
  
  
  METHODS
  Clinical safety study.
  
  
  METHODS
  An academic research environment.
  
  
  METHODS
  Eleven women undergoing abdominal hysterectomy because of abnormal uterine bleeding.
  
  
  METHODS
  Before uterine removal, endometrial cavities were exposed to 15 minutes of recirculatory normal saline heated to 70-85 degrees C.
  
  
  METHODS
  The uteri were analyzed for extent of thermal damage using standard histopathological techniques and tissue viability histochemical staining. Intrauterine pressures and serosal and subserosal temperatures were continuously monitored by computer.
  
  
  RESULTS
  In each treated specimen, histochemical staining demonstrated a depth of necrosis that extended through the entire endometrium and approximately 1-2 mm into the myometrium. The control specimen showed no thermal or mechanical damage. There were no observed negative effects or related complications with this system.
  
  
  CONCLUSIONS
  The computer-controlled system employing continuously circulating hot saline is an effective method to destroy the endometrium. In four cases with clearly patent tubes, no spill was observed. In all 11 patients, serosal and subserosal temperatures were within safe levels (mean temperature, 37 degrees C).
authors.affiliation: Department of Infertility, Instituto Nacional de Perinatología and Instituto Nacional de la Nutricion Salvador Zubiran, Mexico City, Mexico.
authors.forename: H H
authors.initials: HH
authors.lastname: Bustos-Lopez
authors.forename: M
authors.initials: M
authors.lastname: Baggish
authors.forename: R F
authors.initials: RF
authors.lastname: Valle
authors.forename: F
authors.initials: F
authors.lastname: Vadillo-Ortega
authors.forename: V
authors.initials: V
authors.lastname: Ibarra
authors.forename: G
authors.initials: G
authors.lastname: Nava
mesh_terms: D000328:Adult; D004717:Endometrium / Q000187:drug effects* / Q000473:pathology; D005260:Female; D006651:Histocytochemistry / Q000379:methods; D006358:Hot Temperature; D006801:Humans; D007044:Hysterectomy; D008875:Middle Aged; D009336:Necrosis; D011300:Preoperative Care; D012965:Sodium Chloride / Q000008:administration & dosage* / Q000627:therapeutic use; D013194:Staining and Labeling; D013813:Therapy, Computer-Assisted; D014599:Uterus
chemical_list: D012965:Sodium Chloride